Ireland· IE-PA-EU/1/11/669/001-002
Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
A tegafur, kombinationen product containing tegafur + gimeracil + oteracil (as monopotassium salt), registered in Ireland by Nordic Group B.V.. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Tegafur, kombinationen is registered in 9 of 19 countries.
Countries holding a registration under ATC L01BC53 (tegafur, kombinationen), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Tegafur, kombinationen · ATC L01BC53
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Tegafur + Gimeracil + Oteracil (as monopotassium salt)
- Manufacturer
- Nordic Group B.V.
- Country
- Ireland (IE)
- ATC code
- L01BC53
- ATC class
- Tegafur, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/11/669/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tegafur, kombinationen in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaTEYSUNONordic Group BV, Hoofddorp
- SpainTEYSUNO 15 mg/4,35 mg/11,8 mg CAPSULAS DURASNordic Group B.V.
- United KingdomTeysuno 15mg/4.35mg/11.8mg capsulesNordic Pharma Ltd
- IcelandTeysunoNordic Group BV
- NetherlandsTeysuno 15 mg/4,35 mg/11,8 mg harde capsulesNordic Group BV
- NorwayTeysunoNordic Group BV
- PolandTeysunoNordic Group B.V.
- SwedenTeysuno 15 mg/4,35 mg/11,8 mg Kapsel, hårdNordic Group BV
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Teysuno
- Iceland · Teysuno
- Liechtenstein · Teysuno
- Norway · Teysuno
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/76a9e6f3-4406-40c2-bda6-a62dac92cb5f GET /v1/drugs/76a9e6f3-4406-40c2-bda6-a62dac92cb5f?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01BC",
"L01BC53"
],
"strength": null,
"pa_number": "EU/1/11/669/001-002",
"substances": [
"Tegafur",
"Gimeracil",
"Oteracil (as monopotassium salt)"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "14/03/2011",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about tegafur, kombinationen.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.